(fra kommisjonsforordningen)

(1) Commission Regulation (EU) 2021/4682 placed under Union scrutiny and included in Part C of Annex III to Regulation (EC) No 1925/2006, preparations added to food and used in their manufacturing obtained by various processes from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives, from the leaf or fruit of Cassia senna L. containing hydroxyanthracene derivatives and from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives. In its scientific opinion of 22 November 2017 on the safety of hydroxyanthracene derivatives for use in food4 , on which Regulation (EU) 2021/468 was based, the European Food Safety Authority (‘the Authority’) had concluded that hydroxyanthracene derivatives were to be considered as genotoxic and carcinogenic unless there are specific data to the contrary, such as for rhein, and that there was a safety concern for extracts containing hydroxyanthracene derivatives although uncertainty persisted. In line with the Authority’s scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment5 , which considered that no exposure level to genotoxic substances is to be considered without risk, the Authority was unable to provide advice on a daily intake of hydroxyanthracene derivatives that does not give rise to concerns about harmful effects to health. 

(2) Two interested parties submitted files for evaluation to the Authority, within the period provided for in Article 5(2) of Commission Implementing Regulation (EU) No 307/20126 . All the documents submitted by each interested party are listed in Section 2.1 of the Authority`s scientific opinion of 20 March 20247 . 

(3) On the basis of those two files, the Authority consulted stakeholders and the public, in accordance with Article 5c, point (b), of Implementing Regulation (EU) No 307/2012. During the public consultation, eleven additional genotoxicity studies on the relevant preparations were submitted to the Authority. All the documents submitted by each interested party during the public consultation are listed in Appendix A of the scientific opinion of 20 March 2024. 

(4) In its opinion of 20 March 2024, the Authority considered the studies submitted within the period provided for in Article 5(2) of Implementing Regulation (EU) No 307/2012 and those submitted during the public consultation. 

(5) The Authority noted that those studies confirmed the presence of a hydroxyanthracene derivative shown to be genotoxic in vivo in the plant preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids, from the leaf or fruit of Cassia senna L. and from the bark of Rhamnus frangula L. and Rhamnus purshiana DC. 

(6) The Authority further noted that all the submitted genotoxicity studies showed negative results. However, the Authority explained that all the submitted genotoxicity studies had been conducted with plant preparations containing low concentrations of hydroxyanthracene derivatives and considered that the absence of genotoxic results in these studies could not be used to rule out the genotoxicity concern, originating from the presence of a component shown to be genotoxic in vivo in the plant preparations. The Authority further explained that this is in line with its Scientific Committee statement on the genotoxicity assessment of chemical mixtures8 that considers that chemically defined substances have to be assessed individually for their potential genotoxicity and that ‘[i]f a mixture contains one or more chemical substances that are individually assessed to be genotoxic in vivo, the mixture raises concern for genotoxicity’. 

(7) Considering the presence of a compound that was shown to be genotoxic in vivo, the Authority concluded that the plant preparations used in the submitted studies must be considered of concern for genotoxicity. Therefore, the safety of plant preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids, from the leaf or fruit of Cassia senna L. and from the bark of Rhamnus frangula L. and Rhamnus purshiana DC., containing hydroxyanthracene derivatives, could not be established based on the submitted studies. 

(8) Considering that the safety of the plant preparations placed under scrutiny could not be established by the Authority based on the submitted scientific data, those plant preparations should be included in Part A of Annex III to Regulation (EC) No 1925/2006 and be deleted in Part C of that Annex. 

(9) A reasonable period should be provided to allow food business operators to adapt to the new requirements set out in this Regulation. Considering the safety concerns, such period should concern only products already lawfully placed on the market before the entry into force of this Regulation. 

(10) Regulation (EC) No 1925/2006 should therefore be amended accordingly. 

(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,